New Animal Drugs; Changes of Sponsor, 17595-17598 [2013-06126]

Download as PDF Federal Register / Vol. 78, No. 56 / Friday, March 22, 2013 / Rules and Regulations ACTION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 529, and 558 [Docket No. FDA–2013–N–0002] New Animal Drugs; Changes of Sponsor AGENCY: Food and Drug Administration, HHS. Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 21 approved new animal drug applications (NADAs) and 43 approved abbreviated new animal drug applications (ANADAs) from Teva Animal Health, Inc., to Bayer HealthCare LLC. DATES: This rule is effective March 22, 2013. FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for Veterinary Medicine (HFV–100), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855; 240–276–8300; email: steven.vaughn@fda.hhs.gov. Teva Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503 has informed FDA that it has transferred ownership of, and all rights and interest in, the following 21 approved NADAs and 43 approved ANADAs to Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201: SUPPLEMENTARY INFORMATION: TABLE 1—APPLICATIONS TRANSFERRED pmangrum on DSK3VPTVN1PROD with RULES Application No. Trade name 6–391 .................................................................. 6–677 .................................................................. 7–087 .................................................................. 33–157 ................................................................ 40–040 ................................................................ 45–416 ................................................................ 48–287 ................................................................ 55–002 ................................................................ 65–110 ................................................................ 65–498 ................................................................ 91–818 ................................................................ 93–483 ................................................................ 94–170 ................................................................ 99–169 ................................................................ 119–142 .............................................................. 123–815 .............................................................. 124–241 .............................................................. 128–089 .............................................................. 140–270 .............................................................. 141–070 .............................................................. 141–245 .............................................................. 200–042 .............................................................. 200–068 .............................................................. 200–069 .............................................................. 200–108 .............................................................. 200–118 .............................................................. 200–123 .............................................................. 200–124 .............................................................. 200–126 .............................................................. 200–137 .............................................................. 200–147 .............................................................. 200–153 .............................................................. 200–162 .............................................................. 200–174 .............................................................. 200–177 .............................................................. 200–178 .............................................................. 200–181 .............................................................. 200–192 .............................................................. 200–193 .............................................................. 200–202 .............................................................. 200–219 .............................................................. 200–228 .............................................................. 200–230 .............................................................. 200–246 .............................................................. 200–248 .............................................................. 200–253 .............................................................. 200–254 .............................................................. 200–256 .............................................................. 200–265 .............................................................. 200–286 .............................................................. 200–287 .............................................................. 200–293 .............................................................. 200–297 .............................................................. 200–298 .............................................................. 200–319 .............................................................. VerDate Mar<15>2010 15:13 Mar 21, 2013 Jkt 229001 S.Q. (sulfaquinoxaline) 40% Type A Medicated Article. S.Q. (sulfaquinoxaline) 20% Solution. Sulfaquinoxaline Solubilized. SPECTAM (spectinomycin) Scour Halt. SPECTAM (spectinomycin) Injectable Solution. TEVCODYNE (phenylbutazone) Injectable Solution. Oxytetracycline-50 Injectable Solution. TEVCOCIN (chloramphenicol) Injection. PEN–G–MAX (penicillin G procaine) Injectable Suspension. DUAL–CILLIN (penicillin G benzathine and penicillin G procaine). Phenylbutazone Tablets, USP 1 gram. SPECTAM (spectinomycin) Injectable Solution. Phenylbutazone Tablets, USP 100 or 200 mg. Oxytocin Injection. PVL Iron Dextran Injectable (iron hydrogenated dextran injection). Dexamethasone Sodium Phosphate Injection. PVL (oxytocin) Injectable. ZONOMETH (dexamethasone) Solution. SULFASURE (sulfamethazine) SR Cattle Bolus. RAPINOVET (propofol) Injectable Emulsion. TRIBUTAME (embutramide, chloroquine, and lidocaine) Euthanasia Solution. Ketamine Hydrochloride Injection, USP. Oxytetracycline Hydrochloride Injection 100. FERTELIN (gonadorelin diacetate tetrahydrate) Injection. Dexamethasone Solution. Neomycin Oral Solution. MAXIM–200 (oxytetracycline hydrochloride) Injection. Flunixin Meglumine Injection. Phenylbutazone 20% Injection. Gentamicin Sulfate Solution (IU). Gentamicin Sulfate Injection. NEO 200 (neomycin sulfate) Oral Solution. Tripelennamine Hydrochloride Injection. Gentamicin Sulfate Pig Pump Oral Solution. Sulfadimethoxine Injection 40%. Amikacin Sulfate Injection. Amikacin Sulfate Solution. Sulfadimethoxine 12.5% Oral Solution. Clindamycin Hydrochloride Oral Liquid. PHOENECTIN (ivermectin) Oral Solution. Ivermectin Pour-On for Cattle. PHOENECTIN (ivermectin) Injectable Solution. Guaifenesin Injection. Pyrantel Pamoate Oral Suspension (OTC and Rx). Pyrantel Pamoate Oral Suspension. PROSTAMATE (dinoprost tromethamine) Injectable Solution. Iron Dextran Injection—100. Iron Dextran Injection—200. Praziquantel Tablets (OTC and Rx). PHOENECTIN (ivermectin) Paste 1.87%. GBC (gentamicin sulfate, betamethasone valerate, and clotrimazole) Ointment. Furosemide Injection 5%. Ivermectin Chewable Tablets. Clindamycin Hydrochloride Capsules. Acepromazine Maleate Injection. PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 17595 E:\FR\FM\22MRR1.SGM 22MRR1 17596 Federal Register / Vol. 78, No. 56 / Friday, March 22, 2013 / Rules and Regulations TABLE 1—APPLICATIONS TRANSFERRED—Continued Application No. 200–322 200–342 200–351 200–360 200–365 200–382 200–389 200–408 200–463 Trade name .............................................................. .............................................................. .............................................................. .............................................................. .............................................................. .............................................................. .............................................................. .............................................................. .............................................................. Accordingly, the Agency is amending the regulations in 21 CFR parts 510, 520, 522, 524, 529, and 558 to reflect these transfers of ownership. Following these changes of sponsorship, Teva Animal Health, Inc., is no longer the sponsor of an approved application. As such, 21 CFR 510.600 is being amended to remove the entries for this firm. This rule does not meet the definition of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because it is a rule of ‘‘particular applicability.’’ Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801–808. List of Subjects 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. Butorphanol Tartrate Injection. Pyrantel Pamoate Paste. Lincomycin Injectable, USP. TIAGARD (tiamulin) Liquid Concentrate. ROBINUL–V (glycopyrrolate) Injectable. Furosemide Syrup 1%. Amprolium 9.6% Oral Solution. Butorphanol Tartrate Injection. Amprolium-P 9.6% Oral Solution. Authority: 21 U.S.C. 360b. § 520.100 § 520.1870 [Amended] § 520.2043 § 520.446 ■ [Amended] 15. In paragraph (b)(1) of § 520.2043, remove ‘‘000069, 058829, and 059130’’ and in its place add ’’ 000069, 000859, and 058829’’. § 520.447 § 520.2044 [Amended] 6. In paragraph (b) of § 520.447, remove ‘‘000009, 051311, 058829, and 059130’’ and in its place add ‘‘000009, 000859, 051311, and 058829’’. ■ 16. In paragraph (b)(2) of § 520.2044, remove ‘‘059130’’ and in its place add ‘‘000859’’. § 520.2123c [Amended] [Amended] ■ [Amended] 17. In paragraph (b) of § 520.2123c, remove ‘‘059130’’ and in its place add ‘‘000859’’. 7. In paragraph (b)(3) of § 520.1010, remove ‘‘058829 and 059130’’ and in its place add ‘‘000859 and 058829’’. ■ § 520.1044b § 520.2220a [Amended] 8. In paragraph (b) of § 520.1044b, remove ‘‘059130’’ and in its place add ‘‘000859’’. ■ § 520.1192 [Amended] 9. In paragraph (b)(2) of § 520.1192, remove ‘‘051311, 054925, 059130, and 061623’’ and in its place add ‘‘000859, 051311, 054925, and 061623’’. [Amended] 18. In paragraph (a)(1) of § 520.2220a, remove ‘‘000010, 000069, 054925, 057561, and 059130’’ and in its place add ‘‘000010, 000069, 000859, 054925, and 057561’’. ■ ■ § 520.1193 [Amended] PART 510—NEW ANIMAL DRUGS 10. In paragraph (b)(2) of § 520.1193, remove ‘‘051311 and 059130’’ and in its place add ‘‘000859 and 051311’’. 1. The authority citation for 21 CFR part 510 continues to read as follows: § 520.1195 ■ [Amended] 5. In paragraph (b)(1) of § 520.446, remove ‘‘059130’’ and in its place add ‘‘000859’’. ■ ■ 21 CFR Part 558 Animal drugs, Animal feeds. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 510, 520, 522, 524, 529, and 558 are amended as follows: ■ [Amended] § 520.2260b [Amended] 19. In paragraph (f)(1) of § 520.2260b, remove ‘‘059130’’ and in its place add ‘‘000859’’. ■ § 520.2325a [Amended] 20. In paragraph (a)(1) of § 520.2325a, remove ‘‘059130’’ and in its place add ‘‘000859’’. ■ 11. In paragraph (b)(1) of § 520.1195, remove ‘‘050604, 054925, and 059130’’ and in its place add ‘‘000859, 050604, and 054925’’. ■ 2. In § 510.600, in the table in paragraph (c)(1), remove the entry for ‘‘Teva Animal Health, Inc.’’; and in the table in paragraph (c)(2), remove the entry for ‘‘059130’’. § 520.1484 * PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.1720a ■ Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. § 510.600 [Amended] ■ pmangrum on DSK3VPTVN1PROD with RULES 14. In paragraph (b)(2) of § 520.1870, remove ‘‘059130’’ and in its place add ‘‘000859’’. ■ 4. In paragraph (b)(3) of § 520.100, remove ‘‘059130’’ and in its place add ‘‘000859’’. ■ § 520.1010 21 CFR Parts 520, 522, 524, and 529 Animal drugs. [Amended] 3. The authority citation for 21 CFR part 520 continues to read as follows: ■ VerDate Mar<15>2010 15:13 Mar 21, 2013 Jkt 229001 [Amended] 12. In paragraph (b)(3) of § 520.1484, remove ‘‘000009, 054925, 058005, and 059130’’ and in its place add ‘‘000009, 000859, 054925, and 058005’’. ■ [Amended] 13. In paragraph (b)(2) of § 520.1720a, remove ‘‘059130’’ and in its place add ‘‘000859’’. ■ PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 21. In § 520.2455, revise paragraph (b)(2) and add paragraph (b)(3) to read as follows: § 520.2455 Tiamulin. * * * * (b) * * * (2) No. 066104 for the product described in paragraph (a)(1) of this section. (3) No. 000859 for the product described in paragraph (a)(3) of this section. * * * * * E:\FR\FM\22MRR1.SGM 22MRR1 Federal Register / Vol. 78, No. 56 / Friday, March 22, 2013 / Rules and Regulations PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS and 058005’’; and in paragraph (b)(7), remove ‘‘042552 and 059130’’ and in its place add ‘‘000859 and 042552’’. 22. The authority citation for 21 CFR part 522 continues to read as follows: § 522.1192 ■ 34. In paragraph (b)(2) of § 522.1192, remove ‘‘055529, 058005, 059130, and 061623’’ and in its place add ‘‘000859 055529, 058005, and 061623’’. ■ Authority: 21 U.S.C. 360b. § 522.23 [Amended] 23. In paragraph (b)(2) of § 522.23, remove ‘‘059130’’ and in its place add ‘‘000859’’. ■ § 522.56 § 522.1222a [Amended] 35. In paragraph (b) of § 522.1222a, remove ‘‘059130’’ and in its place add ‘‘000859’’. ■ [Amended] 24. In paragraph (b) of § 522.56, remove ‘‘059130’’ and in its place add ‘‘000859’’. ■ § 522.246 [Amended] § 522.1260 [Amended] 36. In paragraph (b)(2) of § 522.1260, remove ‘‘058005 and 059130’’ and in its place add ‘‘000859 and 058005’’. ■ [Amended] 25. In § 522.246, in paragraphs (b)(2) and (b)(3), remove ‘‘059130’’ and in its place add ‘‘000859’’. ■ § 522.1660a [Amended] 26. In paragraph (b) of § 522.390, remove ‘‘059130’’ and in its place add ‘‘000859’’. 37. In paragraph (b) of § 522.1660a, remove ‘‘000010, 000069, 048164, 055529, 057561, 059130, and 061623’’ and in its place add ‘‘000010, 000069, 000859, 048164, 055529, 057561, and 061623’’. § 522.540 § 522.1662a § 522.390 [Amended] ■ [Amended] 27. In § 522.540, in paragraphs (a)(2)(i), (d)(2)(i), and (e)(2), remove ‘‘059130’’ and in its place add ‘‘000859’’; in paragraphs (b)(3)(i), (b)(3)(ii), (c)(3)(i), and (c)(3)(ii), remove the footnote reference ‘‘1’’; and remove the text of footnote 1. ■ § 522.810 [Amended] 28. In paragraph (b) of § 522.810, remove ‘‘059130’’ and in its place add ‘‘000859’’. ■ § 522.1010 [Amended] 39. In paragraph (b) of § 522.1680, remove ‘‘000010, 000856, 059130, 059130, and 061623’’ and in its place add ‘‘000010, 000856, 000859, and 061623’’. ■ [Amended] 41. In § 520.1696b: a. In paragraph (b)(1), remove ‘‘053501, 055529, and 059130’’ and in its place add ‘‘000859, 053501, and 055529’’. ■ b. In paragraph (d)(2)(i)(A), remove ‘‘053501, 055529, 059130, and 061623’’ and in its place add ‘‘000859, 053501, 055529, and 061623’’. ■ c. In paragraph (d)(2)(iii)(B), remove ‘‘055529 and 059130’’ and in its place add ‘‘000859 and 055529’’. ■ ■ [Amended] [Amended] 31. In paragraph (b) of § 522.1066, remove ‘‘059130’’ and in its place add ‘‘000859’’. ■ [Amended] 32. In paragraph (b) of § 522.1086, remove ‘‘037990 and 059130’’ and in its place add ‘‘000859 and 037990’’. pmangrum on DSK3VPTVN1PROD with RULES ■ [Amended] 33. In § 522.1182, in paragraph (b)(1), remove ‘‘042552 and 059130’’ and in its place add ‘‘000859 and 042552’’; in paragraph (b)(6), remove ‘‘058005 and 059130’’ and in its place add ‘‘000859 ■ VerDate Mar<15>2010 15:13 Mar 21, 2013 Jkt 229001 44. In paragraph (b) of § 522.2120, remove ‘‘059130’’ and in its place add ‘‘000859’’. ■ § 522. 2220 [Amended] 45. In paragraph (a)(2)(iii) of § 522.2220, remove ‘‘059130’’ and in its place add ‘‘000859’’. ■ § 522.2615 [Amended] 46. In paragraph (b) of § 522.2615, remove ‘‘053501 and 059130’’ and in its place add ‘‘000859 and 053501’’. ■ PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 47. The authority citation for 21 CFR part 524 continues to read as follows: ■ Authority: 21 U.S.C. 360b. § 524.1044g [Amended] 48. In paragraph (b)(3) of § 524.1044g, remove ‘‘059130’’ and in its place add ‘‘000859’’. ■ § 524.1193 [Amended] 49. In paragraph (b)(2) of § 524.1193, remove ‘‘054925, 059130, and 066916’’ and in its place add ‘‘000859, 054925, and 066916’’. ■ PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS 50. The authority citation for 21 CFR part 529 continues to read as follows: Authority: 21 U.S.C. 360b. § 529.56 [Amended] 51. In paragraph (b) of § 529.56, remove ‘‘059130’’ and in its place add ‘‘000859’’. ■ § 522.1696b 30. In paragraph (b)(4) of § 522.1044, remove ‘‘059130’’ and in its place add ‘‘000859’’. § 522.1182 [Amended] ■ [Amended] 40. In paragraph (b)(2) of § 522.1696a, remove ‘‘055529, 059130, and 061623’’ and in its place add ‘‘000859, 055529, and 061623’’. ■ § 522.1086 § 522.1680 ■ [Amended] 29. In paragraph (b)(3) of § 522.1010, remove ‘‘059130’’ and in its place add ‘‘000859’’. § 522.1066 [Amended] 38. In paragraph (i)(2) of § 522.1662a, remove ‘‘059130’’ and in its place add ‘‘000859’’. ■ § 522.1696a ■ § 522.1044 ■ § 522.2120 17597 § 522.1720 [Amended] 42. In paragraph (b)(1) of § 522.1720, remove ‘‘059130’’ and in its place add ‘‘000859’’. ■ § 522.2005 43. In paragraph (b)(1) of § 522.2005, remove ‘‘059130’’ and in its place add ‘‘000859’’. Frm 00007 Fmt 4700 Sfmt 4700 [Amended] 52. In paragraph (b) of § 529.1044a, remove ‘‘000010, 000061, 000856, 057561, 058005, 059130, and 061623’’ and in its place add ‘‘000010, 000061, 000856, 000859, 057561, 058005, and 061623’’. ■ PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 53. The authority citation for 21 CFR part 558 continues to read as follows: ■ Authority: 21 U.S.C. 360b, 371. § 558.586 [Amended] ■ PO 00000 § 529.1044a [Amended] 54. In paragraph (b) of § 558.586, remove ‘‘059130’’ and in its place add ‘‘000859’’. ■ E:\FR\FM\22MRR1.SGM 22MRR1 17598 Federal Register / Vol. 78, No. 56 / Friday, March 22, 2013 / Rules and Regulations Dated: March 12, 2013. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 2013–06126 Filed 3–21–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket No. USCG–2013–0006] Special Local Regulation; Southern California Annual Marine Events for the San Diego Captain of the Port Zone Coast Guard, DHS. Notice of enforcement of regulation. AGENCY: pmangrum on DSK3VPTVN1PROD with RULES ACTION: SUMMARY: The Coast Guard will enforce the 2013 San Diego Crew Classic Special Local Regulation located in the regulated area encompasses that portion of Mission Bay, San Diego, California bounded by Enchanted Cove, Fiesta Island, Pacific Passage and DeAnza Point, from 7 a.m. to 7 p.m. on April 6, 2013 and 7 a.m. to 7 p.m. on April 7, 2013. This action is necessary to provide to provide for the safety of the participants, crew, spectators, sponsor vessels of the event, and general users of the waterway. During the enforcement period, no spectators shall anchor, block, loiter in, or impede the transit of participants or official patrol vessels in the regulated area during the effective dates and times, unless cleared for such entry by Coast Guard Patrol Commander or through an official supporting vessel. DATES: The regulations in 33 CFR 100.1101 will be enforced from 7 a.m. to 7 p.m. on April 6, 2013 and 7 a.m. to 7 p.m. on April 7, 2013. FOR FURTHER INFORMATION CONTACT: If you have questions on this notice, call or email Petty Officer Bryan Gollogly, Waterways Management, U.S. Coast Guard Sector San Diego, CA; telephone 619–278–7656, email D11-PFMarineEventsSanDiego@uscg.mil. SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the Special Local Regulation for the 2013 San Diego Crew Classic in 33 CFR 100.1101 from 7 a.m. to 7 p.m. on April 6, 2013 and from 7 a.m. to 7 p.m. on April 7, 2013. Under provisions of 33 CFR 100.1101, a vessel may not enter the regulated area, unless it receives permission from the COTP. Spectator vessels may safely transit outside the regulated area but VerDate Mar<15>2010 15:13 Mar 21, 2013 Jkt 229001 may not anchor, block, loiter, or impede the transit of participants or official patrol vessels. The Coast Guard may be assisted by other Federal, State, or Local law enforcement agencies in enforcing this regulation. This notice is issued under authority of 33 CFR 100.1101 and 5 U.S.C. 552(a). In addition to this notice in the Federal Register, the Coast Guard will provide the maritime community with extensive advance notification of this enforcement period via the Local Notice to Mariners. If the Captain of the Port or his designated representative determines that the regulated area need not be enforced for the full duration stated on this notice, he or she may use a Broadcast Notice to Mariners to grant general permission to enter the regulated area. Dated: March 6, 2013. S.M. Mahoney, Captain, US Coast Guard, Captain of the Port San Diego. [FR Doc. 2013–06587 Filed 3–21–13; 8:45 am] BILLING CODE 9110–04–P DEPARTMENT OF EDUCATION 34 CFR Parts 600, 602, 603, 668, 682, 685, 686, 690, and 691 [Docket ID ED–2010–OPE–0004] RIN 1840–AD02 Program Integrity Issues Office of Postsecondary Education, Department of Education. ACTION: Final regulations; revisions to preamble. AGENCY: SUMMARY: On October 29, 2010, the Department of Education published in the Federal Register final regulations for improving integrity in the programs authorized under title IV of the Higher Education Act of 1965, as amended (HEA) (October 29, 2010, final regulations). This document revises the preamble discussion to the October 29, 2010, final regulations in accordance with the remand in Association of Private Sector Colleges and Universities v. Duncan (D.C. Cir. 2012). DATES: These revisions apply to the preamble for the October 29, 2010, regulations (75 FR 66832), which were generally effective July 1, 2011. FOR FURTHER INFORMATION CONTACT: Marty Guthrie, U.S. Department of Education, 1990 K Street NW., Room 8042, Washington, DC 20006. Telephone: (202) 219–7031 or by email at Marty.Guthrie@ed.gov. If you use a telecommunications device for the deaf (TDD), call the PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 Federal Relay Service (FRS), toll free, at 1–800–877–8339. Individuals with disabilities can obtain this document in an accessible format (e.g., braille, large print, audiotape, or compact disc) by contacting the contact person listed in this section. The October 29, 2010, final regulations (75 FR 66832) amended the regulations for Institutional Eligibility Under the HEA, the Secretary’s Recognition of Accrediting Agencies, the Secretary’s Recognition Procedures for State Agencies, the Student Assistance General Provisions, the Federal Family Education Loan (FFEL) Program, the William D. Ford Federal Direct Loan Program, the Teacher Education Assistance for College and Higher Education (TEACH) Grant Program, the Federal Pell Grant Program, and the Academic Competitiveness Grant (AGC) and National Science and Mathematics Access to Retain Talent Grant (National Smart Grant) Programs. This document revises the preamble discussion to the October 29, 2010, final regulations in accordance with the remand in Association of Private Sector Colleges and Universities v. Duncan, 681 F.3d 427 (D.C. Cir. 2012). We note that the Court in APSCU v. Duncan, also remanded certain provisions of the Department’s misrepresentation regulations for revision consistent with the Court’s opinion. We will be publishing a separate notice in the Federal Register addressing this issue. SUPPLEMENTARY INFORMATION: Electronic Access to This Document The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.gpo.gov/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site. You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department. E:\FR\FM\22MRR1.SGM 22MRR1

Agencies

[Federal Register Volume 78, Number 56 (Friday, March 22, 2013)]
[Rules and Regulations]
[Pages 17595-17598]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06126]



[[Page 17595]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 529, and 558

[Docket No. FDA-2013-N-0002]


New Animal Drugs; Changes of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for 21 approved new 
animal drug applications (NADAs) and 43 approved abbreviated new animal 
drug applications (ANADAs) from Teva Animal Health, Inc., to Bayer 
HealthCare LLC.

DATES: This rule is effective March 22, 2013.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855; 240-276-8300; email: 
steven.vaughn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Teva Animal Health, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503 has informed FDA that it has 
transferred ownership of, and all rights and interest in, the following 
21 approved NADAs and 43 approved ANADAs to Bayer HealthCare LLC, 
Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201:

                    Table 1--Applications Transferred
------------------------------------------------------------------------
       Application No.                         Trade name
------------------------------------------------------------------------
6-391........................  S.Q. (sulfaquinoxaline) 40% Type A
                                Medicated Article.
6-677........................  S.Q. (sulfaquinoxaline) 20% Solution.
7-087........................  Sulfaquinoxaline Solubilized.
33-157.......................  SPECTAM (spectinomycin) Scour Halt.
40-040.......................  SPECTAM (spectinomycin) Injectable
                                Solution.
45-416.......................  TEVCODYNE (phenylbutazone) Injectable
                                Solution.
48-287.......................  Oxytetracycline-50 Injectable Solution.
55-002.......................  TEVCOCIN (chloramphenicol) Injection.
65-110.......................  PEN-G-MAX (penicillin G procaine)
                                Injectable Suspension.
65-498.......................  DUAL-CILLIN (penicillin G benzathine and
                                penicillin G procaine).
91-818.......................  Phenylbutazone Tablets, USP 1 gram.
93-483.......................  SPECTAM (spectinomycin) Injectable
                                Solution.
94-170.......................  Phenylbutazone Tablets, USP 100 or 200
                                mg.
99-169.......................  Oxytocin Injection.
119-142......................  PVL Iron Dextran Injectable (iron
                                hydrogenated dextran injection).
123-815......................  Dexamethasone Sodium Phosphate Injection.
124-241......................  PVL (oxytocin) Injectable.
128-089......................  ZONOMETH (dexamethasone) Solution.
140-270......................  SULFASURE (sulfamethazine) SR Cattle
                                Bolus.
141-070......................  RAPINOVET (propofol) Injectable Emulsion.
141-245......................  TRIBUTAME (embutramide, chloroquine, and
                                lidocaine) Euthanasia Solution.
200-042......................  Ketamine Hydrochloride Injection, USP.
200-068......................  Oxytetracycline Hydrochloride Injection
                                100.
200-069......................  FERTELIN (gonadorelin diacetate
                                tetrahydrate) Injection.
200-108......................  Dexamethasone Solution.
200-118......................  Neomycin Oral Solution.
200-123......................  MAXIM-200 (oxytetracycline hydrochloride)
                                Injection.
200-124......................  Flunixin Meglumine Injection.
200-126......................  Phenylbutazone 20% Injection.
200-137......................  Gentamicin Sulfate Solution (IU).
200-147......................  Gentamicin Sulfate Injection.
200-153......................  NEO 200 (neomycin sulfate) Oral Solution.
200-162......................  Tripelennamine Hydrochloride Injection.
200-174......................  Gentamicin Sulfate Pig Pump Oral
                                Solution.
200-177......................  Sulfadimethoxine Injection 40%.
200-178......................  Amikacin Sulfate Injection.
200-181......................  Amikacin Sulfate Solution.
200-192......................  Sulfadimethoxine 12.5% Oral Solution.
200-193......................  Clindamycin Hydrochloride Oral Liquid.
200-202......................  PHOENECTIN (ivermectin) Oral Solution.
200-219......................  Ivermectin Pour-On for Cattle.
200-228......................  PHOENECTIN (ivermectin) Injectable
                                Solution.
200-230......................  Guaifenesin Injection.
200-246......................  Pyrantel Pamoate Oral Suspension (OTC and
                                Rx).
200-248......................  Pyrantel Pamoate Oral Suspension.
200-253......................  PROSTAMATE (dinoprost tromethamine)
                                Injectable Solution.
200-254......................  Iron Dextran Injection--100.
200-256......................  Iron Dextran Injection--200.
200-265......................  Praziquantel Tablets (OTC and Rx).
200-286......................  PHOENECTIN (ivermectin) Paste 1.87%.
200-287......................  GBC (gentamicin sulfate, betamethasone
                                valerate, and clotrimazole) Ointment.
200-293......................  Furosemide Injection 5%.
200-297......................  Ivermectin Chewable Tablets.
200-298......................  Clindamycin Hydrochloride Capsules.
200-319......................  Acepromazine Maleate Injection.

[[Page 17596]]

 
200-322......................  Butorphanol Tartrate Injection.
200-342......................  Pyrantel Pamoate Paste.
200-351......................  Lincomycin Injectable, USP.
200-360......................  TIAGARD (tiamulin) Liquid Concentrate.
200-365......................  ROBINUL-V (glycopyrrolate) Injectable.
200-382......................  Furosemide Syrup 1%.
200-389......................  Amprolium 9.6% Oral Solution.
200-408......................  Butorphanol Tartrate Injection.
200-463......................  Amprolium-P 9.6% Oral Solution.
------------------------------------------------------------------------

    Accordingly, the Agency is amending the regulations in 21 CFR parts 
510, 520, 522, 524, 529, and 558 to reflect these transfers of 
ownership. Following these changes of sponsorship, Teva Animal Health, 
Inc., is no longer the sponsor of an approved application. As such, 21 
CFR 510.600 is being amended to remove the entries for this firm.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, 524, and 529

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510, 
520, 522, 524, 529, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.


Sec.  510.600  [Amended]

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the entry 
for ``Teva Animal Health, Inc.''; and in the table in paragraph (c)(2), 
remove the entry for ``059130''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


Sec.  520.100  [Amended]

0
4. In paragraph (b)(3) of Sec.  520.100, remove ``059130'' and in its 
place add ``000859''.


Sec.  520.446  [Amended]

0
5. In paragraph (b)(1) of Sec.  520.446, remove ``059130'' and in its 
place add ``000859''.


Sec.  520.447  [Amended]

0
6. In paragraph (b) of Sec.  520.447, remove ``000009, 051311, 058829, 
and 059130'' and in its place add ``000009, 000859, 051311, and 
058829''.


Sec.  520.1010  [Amended]

0
7. In paragraph (b)(3) of Sec.  520.1010, remove ``058829 and 059130'' 
and in its place add ``000859 and 058829''.


Sec.  520.1044b  [Amended]

0
8. In paragraph (b) of Sec.  520.1044b, remove ``059130'' and in its 
place add ``000859''.


Sec.  520.1192  [Amended]

0
9. In paragraph (b)(2) of Sec.  520.1192, remove ``051311, 054925, 
059130, and 061623'' and in its place add ``000859, 051311, 054925, and 
061623''.


Sec.  520.1193  [Amended]

0
10. In paragraph (b)(2) of Sec.  520.1193, remove ``051311 and 059130'' 
and in its place add ``000859 and 051311''.


Sec.  520.1195  [Amended]

0
11. In paragraph (b)(1) of Sec.  520.1195, remove ``050604, 054925, and 
059130'' and in its place add ``000859, 050604, and 054925''.


Sec.  520.1484  [Amended]

0
12. In paragraph (b)(3) of Sec.  520.1484, remove ``000009, 054925, 
058005, and 059130'' and in its place add ``000009, 000859, 054925, and 
058005''.


Sec.  520.1720a  [Amended]

0
13. In paragraph (b)(2) of Sec.  520.1720a, remove ``059130'' and in 
its place add ``000859''.


Sec.  520.1870  [Amended]

0
14. In paragraph (b)(2) of Sec.  520.1870, remove ``059130'' and in its 
place add ``000859''.


Sec.  520.2043  [Amended]

0
15. In paragraph (b)(1) of Sec.  520.2043, remove ``000069, 058829, and 
059130'' and in its place add '' 000069, 000859, and 058829''.


Sec.  520.2044  [Amended]

0
16. In paragraph (b)(2) of Sec.  520.2044, remove ``059130'' and in its 
place add ``000859''.


Sec.  520.2123c  [Amended]

0
17. In paragraph (b) of Sec.  520.2123c, remove ``059130'' and in its 
place add ``000859''.


Sec.  520.2220a  [Amended]

0
18. In paragraph (a)(1) of Sec.  520.2220a, remove ``000010, 000069, 
054925, 057561, and 059130'' and in its place add ``000010, 000069, 
000859, 054925, and 057561''.


Sec.  520.2260b  [Amended]

0
19. In paragraph (f)(1) of Sec.  520.2260b, remove ``059130'' and in 
its place add ``000859''.


Sec.  520.2325a  [Amended]

0
20. In paragraph (a)(1) of Sec.  520.2325a, remove ``059130'' and in 
its place add ``000859''.

0
21. In Sec.  520.2455, revise paragraph (b)(2) and add paragraph (b)(3) 
to read as follows:


Sec.  520.2455  Tiamulin.

* * * * *
    (b) * * *
    (2) No. 066104 for the product described in paragraph (a)(1) of 
this section.
    (3) No. 000859 for the product described in paragraph (a)(3) of 
this section.
* * * * *

[[Page 17597]]

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
22. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


Sec.  522.23  [Amended]

0
23. In paragraph (b)(2) of Sec.  522.23, remove ``059130'' and in its 
place add ``000859''.


Sec.  522.56  [Amended]

0
24. In paragraph (b) of Sec.  522.56, remove ``059130'' and in its 
place add ``000859''.


Sec.  522.246  [Amended]

0
25. In Sec.  522.246, in paragraphs (b)(2) and (b)(3), remove 
``059130'' and in its place add ``000859''.


Sec.  522.390  [Amended]

0
26. In paragraph (b) of Sec.  522.390, remove ``059130'' and in its 
place add ``000859''.


Sec.  522.540  [Amended]

0
27. In Sec.  522.540, in paragraphs (a)(2)(i), (d)(2)(i), and (e)(2), 
remove ``059130'' and in its place add ``000859''; in paragraphs 
(b)(3)(i), (b)(3)(ii), (c)(3)(i), and (c)(3)(ii), remove the footnote 
reference ``1''; and remove the text of footnote 1.


Sec.  522.810  [Amended]

0
28. In paragraph (b) of Sec.  522.810, remove ``059130'' and in its 
place add ``000859''.


Sec.  522.1010  [Amended]

0
29. In paragraph (b)(3) of Sec.  522.1010, remove ``059130'' and in its 
place add ``000859''.


Sec.  522.1044  [Amended]

0
30. In paragraph (b)(4) of Sec.  522.1044, remove ``059130'' and in its 
place add ``000859''.


Sec.  522.1066  [Amended]

0
31. In paragraph (b) of Sec.  522.1066, remove ``059130'' and in its 
place add ``000859''.


Sec.  522.1086  [Amended]

0
32. In paragraph (b) of Sec.  522.1086, remove ``037990 and 059130'' 
and in its place add ``000859 and 037990''.


Sec.  522.1182  [Amended]

0
33. In Sec.  522.1182, in paragraph (b)(1), remove ``042552 and 
059130'' and in its place add ``000859 and 042552''; in paragraph 
(b)(6), remove ``058005 and 059130'' and in its place add ``000859 and 
058005''; and in paragraph (b)(7), remove ``042552 and 059130'' and in 
its place add ``000859 and 042552''.


Sec.  522.1192  [Amended]

0
34. In paragraph (b)(2) of Sec.  522.1192, remove ``055529, 058005, 
059130, and 061623'' and in its place add ``000859 055529, 058005, and 
061623''.


Sec.  522.1222a  [Amended]

0
35. In paragraph (b) of Sec.  522.1222a, remove ``059130'' and in its 
place add ``000859''.


Sec.  522.1260  [Amended]

0
36. In paragraph (b)(2) of Sec.  522.1260, remove ``058005 and 059130'' 
and in its place add ``000859 and 058005''.


Sec.  522.1660a  [Amended]

0
37. In paragraph (b) of Sec.  522.1660a, remove ``000010, 000069, 
048164, 055529, 057561, 059130, and 061623'' and in its place add 
``000010, 000069, 000859, 048164, 055529, 057561, and 061623''.


Sec.  522.1662a  [Amended]

0
38. In paragraph (i)(2) of Sec.  522.1662a, remove ``059130'' and in 
its place add ``000859''.


Sec.  522.1680  [Amended]

0
39. In paragraph (b) of Sec.  522.1680, remove ``000010, 000856, 
059130, 059130, and 061623'' and in its place add ``000010, 000856, 
000859, and 061623''.


Sec.  522.1696a  [Amended]

0
40. In paragraph (b)(2) of Sec.  522.1696a, remove ``055529, 059130, 
and 061623'' and in its place add ``000859, 055529, and 061623''.


Sec.  522.1696b  [Amended]

0
41. In Sec.  520.1696b:
0
a. In paragraph (b)(1), remove ``053501, 055529, and 059130'' and in 
its place add ``000859, 053501, and 055529''.
0
b. In paragraph (d)(2)(i)(A), remove ``053501, 055529, 059130, and 
061623'' and in its place add ``000859, 053501, 055529, and 061623''.
0
c. In paragraph (d)(2)(iii)(B), remove ``055529 and 059130'' and in its 
place add ``000859 and 055529''.


Sec.  522.1720  [Amended]

0
42. In paragraph (b)(1) of Sec.  522.1720, remove ``059130'' and in its 
place add ``000859''.


Sec.  522.2005  [Amended]

0
43. In paragraph (b)(1) of Sec.  522.2005, remove ``059130'' and in its 
place add ``000859''.


Sec.  522.2120  [Amended]

0
44. In paragraph (b) of Sec.  522.2120, remove ``059130'' and in its 
place add ``000859''.


Sec.  522.  2220 [Amended]

0
45. In paragraph (a)(2)(iii) of Sec.  522.2220, remove ``059130'' and 
in its place add ``000859''.


Sec.  522.2615  [Amended]

0
46. In paragraph (b) of Sec.  522.2615, remove ``053501 and 059130'' 
and in its place add ``000859 and 053501''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
47. The authority citation for 21 CFR part 524 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


Sec.  524.1044g  [Amended]

0
48. In paragraph (b)(3) of Sec.  524.1044g, remove ``059130'' and in 
its place add ``000859''.


Sec.  524.1193  [Amended]

0
49. In paragraph (b)(2) of Sec.  524.1193, remove ``054925, 059130, and 
066916'' and in its place add ``000859, 054925, and 066916''.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
50. The authority citation for 21 CFR part 529 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


Sec.  529.56  [Amended]

0
51. In paragraph (b) of Sec.  529.56, remove ``059130'' and in its 
place add ``000859''.


Sec.  529.1044a  [Amended]

0
52. In paragraph (b) of Sec.  529.1044a, remove ``000010, 000061, 
000856, 057561, 058005, 059130, and 061623'' and in its place add 
``000010, 000061, 000856, 000859, 057561, 058005, and 061623''.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
53. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.


Sec.  558.586  [Amended]

0
54. In paragraph (b) of Sec.  558.586, remove ``059130'' and in its 
place add ``000859''.


[[Page 17598]]


    Dated: March 12, 2013.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 2013-06126 Filed 3-21-13; 8:45 am]
BILLING CODE 4160-01-P